Zimmer Recalls Versys Heritage Femoral Stems Due to Packaging Validation Issues
Zimmer is recalling Versys Heritage Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that seal integrity testing met acceptance criteria and no illnesses or injuries are reported. This aligns with the rubric for voluntary precautionary recalls where the hazard is theoretical or low-risk.
Plain-English summary
Zimmer, Inc. is recalling the Versys Heritage Fem Stem medical device. The recall involves 7,044,680 units distributed worldwide, including the United States and numerous international markets.
The recall was initiated after Zimmer reviewed historic packaging validations at its Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The review determined that packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing showed that the packaging met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in that specific facility to ensure patient safety.
Healthcare providers and patients should contact Zimmer or their local FDA office for instructions on how to handle the recalled devices. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- VERSYS HERITAGE FEM STEM
- Manufacturer
- Zimmer, Inc.
- Affected units
- 7,044,680
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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